Study to Assess the Pharmacokinetics, Safety and Tolerability of Baloxavir Marboxil in Healthy Chinese Participants

Healthy Volunteer Clinical Trial

Official title:

A Phase I, Single-Centre, Open-Label, Parallel, Two Dose Level Study to Investigate the Pharmacokinetics, Safety, and Tolerability Following a Single Dose of Baloxavir Marboxil in Healthy Chinese Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03959332
• Other study ID #: YP40902
• Status: Completed
• Phase: N/A
• Start date: June 19, 2019
• Est. completion date: July 11, 2019

Study information

• Verified date: July 2020
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will evaluate the pharmacokinetics, safety and tolerability of a single oral dose of baloxavir marboxil (40 mg or 80 mg) in healthy Chinese participants.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: July 11, 2019
• Est. primary completion date: July 11, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 59 Years

Eligibility

Inclusion Criteria:

• Chinese participants must have Chinese parents and grandparents, all of whom were born in China.

• Healthy status as defined by absence of evidence of any active or chronic disease

• Participants whose body weight is =50 to <80 kg and body mass index is =18.5 to <26 kg/m2

Exclusion Criteria:

• Participants with a history of stomach, vagus nerve, or intestinal surgery (except for appendectomy)

• Participants who have a history of allergic symptoms including food allergy (Note:

Non-active allergic rhinitis will be allowed)

• Participants who require chronic drug therapy or those who have used drugs within 3 days prior to screening or within 14 days prior to Day -1

• Participants who have used alcohol-containing, caffeine-containing, grapefruit containing, or St. John's wort-containing products within 72 hours prior to Day -1

• Participants who have used tobacco- or nicotine-containing products within 24 weeks prior to screening

• Participants who have donated > 400 mL of blood within 12 weeks or > 200 mL of blood within 4 weeks prior to screening, or have donated any amount of blood between screening and Day -1

Related Conditions & MeSH terms

• Healthy Volunteer

Intervention

Drug:
• Baloxavir Marboxil
Participants will receive either 40 mg or 80 mg of baloxavir marboxil on Day 1 as a single oral dose.

Locations

Country	Name	City	State
China	Shanghai Xuhui Central Hospital	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
Hoffmann-La Roche	Shionogi

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Plasma Concentration (Cmax)	Baloxavir marboxil and baloxavir concentrations were analyzed by validated Liquid Chromatography with tandem mass spectrometry (LC-MS/MS). Non-compartmental analysis was employed to estimate the PK parameters.	Pre-dose and at 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48,72, 120, 168, 216, 264, and 336 hours post-dose
Primary	Time to Maximum Plasma Concentration (Tmax)	Baloxavir marboxil and baloxavir concentrations were analyzed by LC-MS/MS. Non-compartmental analysis was employed to estimate the PK parameters.	Pre-dose and at 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48,72, 120, 168, 216, 264, and 336 hours post-dose
Primary	Area Under the Concentration to Time Curve From Time 0 to Infinity (AUC0-inf)	Baloxavir marboxil and baloxavir concentrations were analyzed by LC-MS/MS. Non-compartmental analysis was employed to estimate the PK parameters.	Pre-dose and at 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48,72, 120, 168, 216, 264, and 336 hours post-dose
Primary	Area Under the Concentration to Time Curve From Time 0 to Last Quantifiable Concentration (AUC0-last)	Baloxavir marboxil and baloxavir concentrations were analyzed by LC-MS/MS. Non-compartmental analysis was employed to estimate the PK parameters.	Pre-dose and at 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48,72, 120, 168, 216, 264, and 336 hours post-dose
Primary	Area Under the Concentration to Time Curve From Time 0 to Time t (AUC0-t)	Time t may be chosen as a time point where evaluable concentrations are available in at least 90% of participants. Baloxavir marboxil and baloxavir concentrations were analyzed by LC-MS/MS. Non-compartmental analysis was employed to estimate the PK parameters.	Pre-dose and at 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48,72, 120, 168, 216, 264, and 336 hours post-dose
Primary	Terminal Elimination Half-Life (T1/2)	Baloxavir marboxil and baloxavir concentrations were analyzed by LC-MS/MS. Non-compartmental analysis was employed to estimate the PK parameters.	Pre-dose and at 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48,72, 120, 168, 216, 264, and 336 hours post-dose
Primary	Apparent Total Oral Clearance (CL/F)	Baloxavir marboxil and baloxavir concentrations were analyzed by LC-MS/MS. Non-compartmental analysis was employed to estimate the PK parameters.	Pre-dose and at 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48,72, 120, 168, 216, 264, and 336 hours post-dose
Primary	Apparent Oral Volume of Distribution (Vz/F)	Baloxavir marboxil and baloxavir concentrations were analyzed by LC-MS/MS. Non-compartmental analysis was employed to estimate the PK parameters.	Pre-dose and at 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48,72, 120, 168, 216, 264, and 336 hours post-dose
Primary	Plasma Concentrations 24 (C24), 48 (C48), and 72 Hours (C72) Postdose	Baloxavir marboxil and baloxavir concentrations were analyzed by LC-MS/MS. Non-compartmental analysis was employed to estimate the PK parameters.	24, 48 and 72 hours postdose
Secondary	Percentage of Participants With Adverse Events (AEs)		Up to Day 15